As we move into the new year, you can expect some changes to be happening within the regulatory environment. One notable recent development involves the issuance of the FDA's recent proposed rule, titled, "Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products."

Janet Woodcock, M.D., the director of FDA's Center for Drug Evaluation and Research, released a statement on the FDA website describing the rationale behind the proposed rule.

Dr. Woodcock wrote, "FDA is issuing a proposed rule that would allow generic drug manufacturers to independently update and promptly distribute revised product labeling — just like brand name manufacturers – before FDA reviews or approves the change. Empowering generic drug companies to update their own drug safety information is intended to provide them the incentive to more actively participate with FDA in ensuring the timeliness, accuracy, and completeness of this information. The brand manufacturer would be expected to consider the information provided by the generic drug manufacturer as part of its review and evaluation of adverse drug experience information for its drug. And to make sure that the drug safety information updates from both generic and brand name companies are readily available to health care professionals and the public, FDA plans to post these updates on its website."

The FDA decided to extend the comment period on this document 60 days further than it had originally planned in an effort to gather additional input from the industry. This comment period closed on January 13, 2014. If you would like to read through the new proposed rule, it can be found on the Federal Register's website or you can click here.

Med-ERRS is looking forward to seeing this new proposed rule become finalized. We will be sure to include the link to the finalized rule in a future newsletter when it becomes available.

On at least two occasions at a hospital, when a request was made for a 5 unit dose of tuberculin purified protein derivative (PPD), the pharmacy inadvertently dispensed an entire 1 mL vial of tuberculin 5 units/0.1 mL (10 doses). The labeling on the vial carton states that there are 10 doses in each vial. However, once removed from the carton, the vial's front label panel states only 5 units/0.1 mL (see image below.) One must then turn the vial around to see additional information that notes there are 10 doses in the vial. A nurse may recognize that the correct dose is 5 units (0.1 mL), particularly given that 0.1 mL is the maximum volume of solution typically administered by the intradermal route. However, PPD has been in short supply, and it's been difficult for some hospitals to obtain even a single vial--all the more reason for the company to improve the label and to be sure everyone is aware of this situation. All PPD doses should be dispensed from the pharmacy in unit-dose intradermal syringes containing the proper dose.

ISMP Medication Safety Alert, Acute Care: Volume 18, Issue 21

Cardizem or Cardene?

An emergency department (ED) nurse prepared and administered a CARDENE (niCARdipine) infusion instead of the prescribed CARDIZEM (diltiazem) infusion. The patient received the wrong medication for several hours before the mistake was discovered. The patient became hypotensive during the infusion, but he was quickly treated so there was no permanent harm and no futher medication management was required. In another recently reported mix-up with these drugs, a nurse programmed a smart pump to infuse Cardizem instead of Cardene. The patient received the correct medication but at the wrong rate until the mistake was caught by a nurse on the next shift. Again, no harm was reported. In an earlier case in which a mix-up occurred in the pharmacy at the time of dispensing, Cardizem was sent instead of Cardene, and a nurse later assumed this was an intentional pharmacy substitution and did not question the change.

Although not a factor in the recent events, mix-ups are also likely if the mnemonic for the drugs start with C-A-R-D. The two drugs are not on our list of commonly confused drug names maintained by ISMP, so we will be adding the pair.

ISMP Medication Safety Alert, Acute Care: Volume 18, Issue 23

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